ORCHID
- Conditions
- asal Polyposis
- Registration Number
- JPRN-jRCT2080224984
- Lead Sponsor
- AstraZeneca KK
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 40
1. Female or male patients aged 18 to 75 years inclusive
2. Stable Intranasal corticosteroids (INCS) use for at least 4 weeks prior to enrolment and throughout screening
3. History of treatment with systemic corticosteroids (SCS) or prior surgery for CRSwNP
4. Bilateral sinonasal polyposis with a nasal polyp score (NPS) of 5 at enrolment and randomization (unilateral score of at least 2 for each nostril)
5. Ongoing symptoms for at least 12 weeks prior to enrolment
6. Patient-reported moderate to severe nasal blockage score (NBS) 2 or more at enrolment
7. Bi-weekly mean NBS 1.5 or more at randomization
8. SNOT-22 total score 20 or more at enrolment and randomization
9. Documented physician-diagnosed asthma
10. Blood eosinophil count of >2% or 150/microL or more at enrolment
1. Any nasal and/or sinus surgery within 3 months prior to enrolment
2. Patients with conditions that makes them non evaluable for the co-primary efficacy endpoint including but not limited to:
- Unilateral antrochoanal polyps
- Nasal septal deviation that occludes at least one nostril
- Current rhinitis medicamentosa
- Allergic fungal rhinosinusitis or allergic fungal sinusitis;
3. Clinically important comorbidities that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results
4. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period.
5. Receipt of any marketed or investigational biologic product within 6 months of enrolment
6. Currently pregnant or breastfeeding
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>exploratory<br>pharmacokinetics<br>-
- Secondary Outcome Measures
Name Time Method safety<br>efficacy<br>exploratory<br>pharmacokinetics<br>-